MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)— 510(k) K973230

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K973230 for MONARCH (IN 2125)/INTELLISYSTEM (IN 1125), Substantially Equivalent on 1997-11-25. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1997-08-27
Decision date: 1997-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.